(116 days)
No reference device were used in this submission.
No
The device description and performance studies focus on the chemical composition and physical properties of an etching gel, with no mention of AI or ML technologies.
No
The device is an etching gel used in dental procedures to prepare surfaces for bonding, not to treat or cure a disease or condition.
No
Explanation: The device is a hydrofluoric acid etching gel used for preparing dental restorations prior to bonding and cementation. It does not perform any diagnostic function such as identifying, confirming, or monitoring a disease or condition.
No
The device is a hydrofluoric acid etching gel, which is a chemical substance and not a software-only medical device. The description clearly outlines its chemical composition and physical form.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for extraoral etching of dental restorations prior to bonding and cementation. This is a procedure performed on a material (porcelain/ceramic) outside of the body, not on a biological sample taken from the body.
- Device Description: The device is a chemical etching gel applied directly to the restoration. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical components or processes associated with IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely for preparing a dental restoration material.
N/A
Intended Use / Indications for Use
Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
Product codes
KLE, EIH, PME
Device Description
HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast.
HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Through real-time stability testing, the shelf life of the subject device is reliable and effective within 2 years.
The physical properties of the subject device, including Thermostability, Hydrofluoric acid content, Rotational viscosity value and pH value, were determined and tested according to Internal standard SOP of the company, and the test results demonstrated the qualification and substantial equivalence when compared to the predicate device.
Additionally, the subject device is substantially equivalent to the predicate device that has been legally marketed already and with no clinical adverse events. The compositions of the subject device do not contain any non-conventional chemicals compared to the legally marketed predicate device. According to International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the subject device does NOT contact the patient's body directly, and Biocompatibility Evaluation Endpoints are not applicable and biocompatibility tests are not required accordingly. And the biocompatibility analysis is sufficient to prove the safety of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference device were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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December 20, 2024
Rizhao HuGe Biomaterials Company, Ltd. Maggie Zheng Regulatory Affairs Manager No.2 North Zhaoyang Road, District of Donggang Rizhao City, 276800 CHINA
Re: K242530
Trade/Device Name: HF-Etchant Hydrofluoric Acid Etching Gel Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, EIH, PME Dated: August 24, 2024 Received: August 26, 2024
Dear Maggie Zheng:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
HF-Etchant Hydrofluoric Acid Etching Gel
Indications for Use (Describe)
Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K242530
510 (k) Summary
This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
1. Date Summary Prepared: December 19, 2024
2. Submitter Information:
| Owner's Name | Rizhao HuGe Biomaterials Company, Ltd. |
|---|---|
| Address | No.2 North Zhaoyang Road, District of Donggang, Rizhao City, |
| Shandong Province, China 276800 | |
| Telephone | 0086 633 2277268 |
| Fax | 0086 633 2277298 |
| Contact Person | Ms. Maggie Zheng |
| Contact Title | Regulatory Affairs Manager |
| zhengxy@hugedent.com |
3. Device Name
Trade name: HF-Etchant Hydrofluoric Acid Etching Gel Common name: Hydrofluoric Acid Etching Gel Classification name: Resin Tooth Bonding Agent (21 CFR 872.3200) Regulatory Class: II Product Code: KLE, EIH, PME
4. Predicate Device Information
| Owner/Operator | Device Trade Name | 510 (k) No. | Product Code |
|---|---|---|---|
| Liaoning Upcera Co., Ltd | Ceramic Etchant (HF-5 and | ||
| HF-9) | K240153 | KLE, EIH, PME |
No reference device were used in this submission.
5. Description of Device
HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable
5
dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast.
HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.
6. Indications for Use
Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
7. Technological Characteristics Comparison
All components of the subject device are based upon industry well-known chemistry. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate device.
| Technological
Characteristics | Subject device
(HF-Etchant Hydrofluoric Acid Etching
Gel) | Predicate device
K240153 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition
of Materials | Water, hydrofluoric acid, thickening agent
and pigment. | Water, hydrofluoric acid, thickening agent
and pigment. |
| Indications of Use | Used for extraoral etching of various
types of resin bonded porcelain/ceramic
restorations (veneers, crowns, and inlays)
prior to the bonding and cementation
procedure. | Ceramic Etchant is intended for etching
the porcelain veneers, crowns, and inlays
extraorally. It is also used for pretreating
the porcelain veneers, crowns, and inlays
extraorally before bonding. |
| Clinical condition | Conditioning of porcelain/ceramic surface | Conditioning of porcelain/ceramic surface |
| Time for use | 10-60 seconds | 20-40 seconds |
| Water Solubility | Soluble | Soluble |
| Contact with human
body | Etching in vitro | Etching in vitro |
| Prescription/over-
the-counter use | Prescription | Prescription |
| Physical form | Gel | Gel |
| Delivery form | Syringe | Syringe |
| Physical Properties | The subject device and the predicate device have substantially equivalent physical
properties as they all conform to HUGE SOP. | |
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The technological characteristics of the subject device are very similar to those of the predicate device. The subject device is a similar product, manufactured with similar materials and used in the same way by the same types of users and patient populations. The subject device and the predicate device have minor difference in Composition of Materials. However, the difference does not affect the intended use or substantial equivalence. Besides, other comparison items such as Clinical condition, Time for use, Water Solubility, Contact with human body, Physical form, Delivery form and Physical Properties, etc. are the same or very similar. And both of the subject device and the predicate device are supplied for prescription use.
8. Summary of Non-clinical testing
Through real-time stability testing, the shelf life of the subject device is reliable and effective within 2 years.
The physical properties of the subject device, including Thermostability, Hydrofluoric acid content, Rotational viscosity value and pH value, were determined and tested according to Internal standard SOP of the company, and the test results demonstrated the qualification and substantial equivalence when compared to the predicate device.
Additionally, the subject device is substantially equivalent to the predicate device that has been legally marketed already and with no clinical adverse events. The compositions of the subject device do not contain any non-conventional chemicals compared to the legally marketed predicate device. According to International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the subject device does NOT contact the patient's body directly, and Biocompatibility Evaluation Endpoints are not applicable and biocompatibility tests are not required accordingly. And the biocompatibility analysis is sufficient to prove the safety of the subject device.
9. Summary of Clinical testing
Clinical test is not applicable.
10. Conclusions
Based on the indications for use, technological characteristics, performance testing and comparison to the predicate device, the subject device has been shown to be safe and effective for its intended use and the minor differences in composition of the predicate device affecting neither the general intended use nor substantial equivalence. Rizhao HuGe Biomaterials Company, Ltd. concludes that the subject device is substantially equivalent to the predicate
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Image /page/7/Picture/0 description: The image shows the word "HUGE" in large, bold, orange letters. The letters are stacked horizontally, taking up most of the image space. A thin black line is located underneath the word "HUGE".
device described herein.